MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 4122201

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Hypervolemia (2664); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure the operator noticed that the return saline roller clamp was not at the saline line, but was on the return line and there were 3 minutes of return pressure high alarms.The initial volume of the saline was 1000 cc and there was no record taken regarding the volume of the saline left in the saline bag.Per the customer the calculated final fluid balance was 101%.Patient id and age are unknown at this time.There was no reported medical intervention for this event.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed the final fluid balance was at 113%.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure the operator noticed that the return saline roller clamp was not at the saline line, but was on the return line and there were 3 minutes of return pressure high alarms.The initial volume of the saline was 1000 cc and there was no record taken regarding the volume of the saline left in the saline bag.Per the customer the calculated final fluid balance was 101%.Patient id and age are unknown at this time.There was no reported medical intervention for this event.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 18492213
• MDR Text Key: 333204410
• Report Number: 1722028-2024-00013
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4122201
• Device Lot Number: 2307123141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 60 KG